BEUDAMED
    FDA Adverse Event Death Summary report: N

    INVACARE

    MDR report key: 1100563 · Received August 6, 2008

    Report

    Report Number
    MW5007901
    Event Type
    Death
    Date Received
    August 6, 2008
    Date of Event
    July 20, 2008
    Report Date
    August 6, 2008
    Manufacturer
    INVACARE CORP
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS FOUND BY THE HOME CARE AIDE OVER THE EDGE OF HER HOSP BED WITH A LOW AIR LOSS MATTRESS AND HALF SIDE RAILS. LIGATURE MARKS WERE NOTED ON THE PT'S NECK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INVACARE BED HALF SIDE RAILS FNL INVACARE CORP BAR6640IVC *
    2 INVACARE MICRO AIR 3500 LOW AIR LOSS FNL INVACARE CORP. BB9572000

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death INVACARE BED HALF SIDE RAILS| INVACARE MICRO AIR 3500 LOW AIR LOSS MATTRESS